Implementation Workflows
Step-by-step guides for common MDR/IVDR compliance tasks
1
New Medical Device Procurement Workflow
From requirement identification to device acceptance
Step 1
Clinical Need Assessment
- • Document clinical requirement and intended use
- • Identify patient population and use environment
- • Consult with end-users (clinicians, technicians)
- • Define essential performance requirements
Key Question: Is this a medical device under MDR definition?
Step 2
Regulatory Status Verification
- • Confirm CE marking (MDR or legacy MDD until validity expires)
- • Check EUDAMED registration status (when available)
- • Verify Notified Body certificate validity
- • Confirm device classification matches intended use
- • Check UDI-DI in EUDAMED database
Red Flag: No valid CE certificate or expired NB certification
Step 3
Supplier Verification
- • Identify economic operator role (manufacturer, AR, importer, distributor)
- • Verify importer labelling compliance if applicable
- • Request Declaration of Conformity
- • Obtain IFU in local language(s)
- • Confirm post-market surveillance contact details
Step 4
Technical Evaluation
- • Review IFU for installation, maintenance, and training requirements
- • Assess compatibility with existing systems (IT, infrastructure)
- • Evaluate cybersecurity requirements for connected devices
- • Check reprocessing requirements (if applicable)
- • Identify any accessories or consumables required
Step 5
Procurement Decision & Ordering
- • Complete procurement approval with all stakeholders
- • Include regulatory compliance requirements in contract
- • Specify FSCA notification obligations
- • Define incident reporting responsibilities
- • Place order with traceability documentation
Step 6
Device Acceptance
- • Verify delivery matches order (model, quantity, accessories)
- • Check packaging integrity and transport conditions
- • Record UDI-DI and UDI-PI (lot/serial numbers)
- • Verify all documentation received (IFU, DoC, certificates)
- • Complete acceptance testing per IFU requirements
- • Register device in hospital asset management system
Documentation: Complete Device Acceptance Record with UDI and traceability data
Step 7
Training & Deployment
- • Complete user training per IFU requirements
- • Document training attendance and competency
- • Deploy device to clinical area
- • Establish maintenance schedule
- • Set up FSCA notification pathway
2
Incident Reporting Workflow
From incident detection to regulatory notification
IMMEDIATE
Patient Safety First
- • Ensure patient safety - remove from harm if applicable
- • Provide necessary medical treatment
- • Isolate the device - DO NOT discard, modify, or clean
- • Preserve all packaging, accessories, and consumables
- • Secure any connected data (logs, alarms)
Step 1
Initial Documentation (Within 24 hours)
- • Document date, time, location of incident
- • Record device identification (UDI, model, serial, lot)
- • Describe the incident factually (what happened)
- • Document patient outcome/harm if any
- • Record names of witnesses and staff involved
- • Take photographs of device, display, labels if appropriate
Step 2
Classify the Incident
Serious Incident (Must Report)
- • Death of patient, user, or other person
- • Serious deterioration in health
- • Fetal distress/death or abnormality
- • Life-threatening illness or injury
- • Permanent impairment of body function
- • Hospitalization or prolongation
- • Medical/surgical intervention required
Near Miss (Document & Monitor)
- • Malfunction without patient harm
- • Potential to cause serious incident
- • If repeated, could lead to harm
- • User intervention prevented harm
Step 3
Internal Notification
- • Notify clinical risk management/patient safety
- • Inform medical device management team
- • Alert department head/clinical lead
- • Complete internal incident report form
Step 4
Manufacturer Notification
- • Contact manufacturer using designated reporting channel
- • Provide incident details and device identification
- • Request manufacturer reference number
- • Agree on device investigation arrangements
- • Document manufacturer response
Note: Manufacturer has 15 days to report serious incidents to Competent Authority
Step 5
Competent Authority Reporting
- • Many Member States require healthcare facilities to report directly
- • Use national reporting system (e.g., MHRA Yellow Card, BfArM, ANSM)
- • Include all documented information
- • Retain copy of submission and any acknowledgment
Timeline: Report within timeframes specified by national legislation
Step 6
Follow-up & Closure
- • Cooperate with manufacturer investigation
- • Review investigation findings
- • Implement any corrective actions identified
- • Update internal records with conclusions
- • Share lessons learned within organization
- • Close incident file with full documentation
3
Field Safety Corrective Action (FSCA) Response Workflow
From notification receipt to action completion
Step 1
Receive & Acknowledge FSN
- • Log Field Safety Notice (FSN) receipt with date and source
- • Verify FSN authenticity (check EUDAMED, manufacturer website)
- • Acknowledge receipt to manufacturer within timeframe specified
- • Assign responsible person for action management
Step 2
Assess Scope & Impact
- • Identify affected devices in your inventory using UDI/lot/serial
- • Determine locations of affected devices
- • Assess patient exposure (if any patients currently using)
- • Review required actions (recall, modification, monitoring)
- • Determine urgency level
Step 3
Communicate Internally
- • Alert affected clinical departments
- • Brief clinical staff on safety issue and required actions
- • Provide interim guidance if devices must remain in use
- • Inform risk management and quality teams
Step 4
Implement Corrective Actions
If RECALL:
- • Remove devices from use
- • Quarantine in designated area
- • Arrange return to manufacturer
- • Obtain replacement devices
If MODIFICATION:
- • Schedule manufacturer visit
- • Implement software update
- • Apply hardware modification
- • Verify successful completion
Step 5
Patient Management (If Required)
- • Identify patients with implanted/active affected devices
- • Conduct clinical risk assessment
- • Schedule patient reviews/follow-ups as needed
- • Communicate with patients per FSN guidance
- • Document all patient contacts and outcomes
Step 6
Confirm & Close
- • Verify all required actions completed
- • Submit action completion confirmation to manufacturer
- • Update asset management records
- • Archive FSN and all related documentation
- • Review for systemic learning opportunities
4
In-House Device Manufacturing Assessment Workflow
Article 5(5) exemption evaluation for healthcare institutions
Step 1
Identify Need for In-House Manufacturing
- • Document specific patient need that cannot be met by market devices
- • Search EUDAMED and market for suitable CE-marked alternatives
- • If suitable device exists at ANY approved supplier, cannot use exemption
- • Document market search methodology and results
Step 2
Verify All 7 Conditions Are Met
Condition 1: No equivalent CE-marked device available on market
Condition 2: Device not transferred to another legal entity
Condition 3: Manufactured under appropriate QMS
Condition 4: Used only in healthcare institution premises
Condition 5: Industrial scale processes not used
Condition 6: Manufacturing reviewed by responsible person
Condition 7: Member State requirements for declaration/documentation met
Step 3
Establish QMS & Documentation
- • Develop device specification and intended purpose
- • Perform and document risk assessment
- • Establish design and production procedures
- • Define verification and validation requirements
- • Create instructions for use
- • Establish traceability system
Step 4
Submit Declaration (If Required)
- • Check national requirements for declaration/notification
- • Submit declaration to Competent Authority if required
- • Include justification, device description, and QMS summary
- • Maintain records for inspection
Step 5
Ongoing Compliance
- • Review market availability periodically
- • Monitor device performance and incidents
- • Update documentation as needed
- • Be prepared for Competent Authority inspection